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This paper aims to review several related papers on Quality Management and Industry 4.0 in the pharmaceutical industry environment to achieve the benefits required future and give a better vision of the extant regulatory and technical barriers for realizing it. Quality Management and industry 4.0 require efforts to better understand a GMP (Good Manufacturing Practices) pharmaceutical industry situation. Product quality in the pharmaceutical industry is a fundamental thing that must be achieved as a fulfillment of regulatory requirements. GMP for the Pharmaceutical Industry is a minimum standard of compliance for the pharmaceutical quality system requirement that must be designed, applied, managed, and maintained properly so that the main objective is achieved where the production process so that medicinal products always have robust quality in fulfilling efficacy and patient safety. Industry 4.0 in the pharmaceutical industry (which is popular with the term Pharma 4.0) is challenging to implement within the GMP 'high-regulated industry' environment. It will have consequences to moving transition into it step by step in a delicate careful slide. The internet of things (IoT), artificial intelligence (AI), robotics, machine learning, cyber-physical system, and advanced computing as a character of industry 4.0 will dramatically change the landscape of manufacturing including the quality system inside. The research results presented in this paper show an increasing trend towards research that focuses on the slices of 'quality management', 'pharmaceutical quality system' and 'industry 4.0'. Further research needs to be done to create a pharma 4.0 quality system implementation model. [ABSTRACT FROM AUTHOR]

The application of digital interventions in healthcare beyond research has been translated in the development of software as a medical device. Along with corresponding regulations for medical devices, there is a need for assessing adverse events to conduct post-market surveillance and to appropriately label digital health interventions to ensure proper use and patient safety. To date unexpected consequences of digital health interventions are neglected or ignored, or at least remain undescribed in literature. This paper is intended to raise awareness across the research community about these upcoming challenges. We recommend that - together with developing a new research field of digitalovigilance - a systematic assessment and monitoring of adverse events and unexpected interactions be included in clinical trials, along with the reporting of such events and the conduct of meta-analyses on critical aspects. [ABSTRACT FROM AUTHOR]

Artificial intelligence is revolutionizing healthcare in a variety of ways, including diagnosis, treatment, and follow-up. Self-care data can be collected and managed more efficiently with the help of electronic health (E-health). Patient information about their healthcare is rarely shared on the web, even though health care is a popular subject on the cyberspace. The primary objective is to investigate the impact on E-health information obtained using artificial intelligence (AI). A secondary goal of this article is an overview of the various facets of E-health as it pertains to the health care system. Recent frameworks have been examined and their practical applications thoroughly examined in the current paper. The effects of knowledge on E-health can bebroken down into a number of subcategories. According to the findings, clinics can more easily share information thanks to the capabilities of modern information as well as digital technologies. Also, significant improvement in patient safety can be achievedthrough better knowledge-sharing practices, according to the outcomes. [ABSTRACT FROM AUTHOR]

One of the problems in the hospital's drug inventory is a great loss due to shortage of drug supplies that impact to patients safety and excess storage of drugs in excess of what is needed. Therefore, we need an appropriate inventory policy system for managing drug inventory in hospitals. In this paper, we discuss a hybrid policy drug inventory model with deterministic demand for a single product that combined periodic and continuous review systems. The periodic review system that used in this paper is (s, S) policy. It means that periodical replenishment depend on s and S, if inventory position reach or below s, then a replenishment is placed to raise the inventory position up to S. Meanwhile, the continuous review system that used is (R, Q). Whenever inventory position fall to R, then a replenishment for Q units is placed. Thus, the hybrid policy drug inventory model mix the periodic (s, S) policy and continuous (R, Q) policy. A long-run average cost per hour is used as an objective function in the model. The characteristic of the objective function is investigated and it results that the objective function is a quasi-convex function. Based on the properties of the objective function in the model, the Branch and Bound and Kuhn-Tucker method can be used to determine the optimal long-run average cost per unit of time. [ABSTRACT FROM AUTHOR]

The process of administrating anaesthesia into the patient's body is very crucial during any surgery. The intravenous method of anesthetic drug delivery is widely used in comparison to inhale as they provide steady maintenance and recovery rate is faster. The anaesthetist administers a regulated dosage of anaesthesia to the patient which depends on the essential body functioning parameters such as heart rate, depth of anaesthesia, body temperature etc. Conventionally anaesthesia is administered manually which may lead to anesthetic complications due to inappropriate dosing. To reduce the chances of anaesthesia complications, a system has been proposed which automatically regulates the anaesthesia dosage. The objective of this work is to design and develop a prototype device for assisted intravenous anaesthesia delivery system that would help to administer anaesthesia as per the specific requirement of the patients undergoing surgeries. The prototype device has an embedded PID based control algorithm that help anaesthesiologist to calculate and regulate dosage of the drug at various stages of the surgery. To ensure highest safety for the patients, various sensors have also been integrated into the device that simultaneously track critical parameters like Bi-spectral Index, temperature, pulse oximetry and cardiography and in case of deviations generate alarm for immediate corrective action. [ABSTRACT FROM AUTHOR]

Medication errors are a leading cause of preventable harm in hospitals. Electronic medication systems (EMS) have shown success in reducing the risk of prescribing errors, but considerable less evidence is available about whether these systems support a reduction in medication administration errors in paediatrics. Using a stepped wedge cluster randomized controlled trial we investigated changes in medication administration error rates following the introduction of an EMS in a paediatric referral hospital in Sydney, Australia. Direct observations of 284 nurses as they prepared and administered 4555 medication doses was undertaken and observational data compared against patient records to identify administration errors. We found no significant change in administration errors post EMS (adjusted Odds Ratio [aOR] 1.09; 95% CI 0.89-1.32) and no change in rates of potentially serious administration errors (aOR 1.18; 95%CI 0.9-1.56), or those resulting in actual harm (aOR 0.92; 95%CI 0.34-2.46). Errors in administration of medications by some routes increased post EMS. In the first 70 days of EMS use medication administration error rates were largely unchanged. [ABSTRACT FROM AUTHOR]

The safety of patients in hospital services and primary care services in family medicine centers is and should be primary of every health professional or public, private or public-private health institution. Patients are not only harmed by the misuse of technology, various medical actions, they can also be harmed by poor communication between them, different health care providers or delays in receiving treatment. The purpose of this paper was what the Nurses think about the safety of patients in the Regional Hospital in Gjakova and Family Medicine Centers in the Municipality of Gjakova. The method used to conduct this study was through a questionnairequantitative and descriptive questionnaire.100 nurses participated and the questionnaire that presented the data is HSOPS (Hospital Survey on Patient Safety). This questionnaire has nine dimensions and all questions are closed with answers from 1 to 5. From the results of the research we notice that in the Regional Hospital of Gjakova the safety of patients is at a level and that the more security that patients have within the hospital services the easier it is to cope with hospitalization where 73% of nurses state that they have no problem with the safety of their patients. The nurses in the Regional Hospital of Gjakova emphasized that they are always informed about the errors that occur in the patient with 91% while the nurses in the family medicine centers were less informed with 48%. Nurses of health institutions in Gjakova have reported that nursing errors in their work have brought positive changes by 82%. Nurses report something that negatively affects patient care 72% in both health institutions. Conclusion: There is no such change that classifies nurses who say they do not perform any activity to maintain patient safety in Hospital wards and Family Medicine Centers. Primary health care nurses had no knowledge of what would be their safety and that of their patients receiving health care compared to secondary health care nurses who were constantly engaged in eliminating errors at work, improving them in quality and did activities to improve patient safety. [ABSTRACT FROM AUTHOR]

The Intensive Care Unit (ICU) is an information-intense environment where more patient data points are recorded than in other wards. The electronic Record for Intensive Care (eRIC) is an ICU information system that integrates patient data every minute from multiple systems. Once implemented across New South Wales (NSW), eRIC will be one of the largest system-wide ICU clinical information systems in the world. This study explored experiences with the use of eRIC by ICU clinicians at an Australian metropolitan teaching hospital. Semistructured, in-depth interviews relating to physician electronic test management processes were conducted with 11 ICU clinicians and one clinical information system manager was observed in their use of the system. The introduction of eRIC resulted in an additional patient record, which was perceived to hold implications for workflow and patient safety. Study findings are valuable for informing implementation as the rollout of eRIC continues. [ABSTRACT FROM AUTHOR]

We document the procedure and performance of a rule-based NLP system that, using transfer learning, automatically extracts essential named entities related to drug errors from Japanese free-text incident reports. Subsequently, we used the rule-based annotated data to fine-tune a pre-trained BERT model and examined the performance of medication-related incident report prediction. The rule-based pipeline achieved a macro-F1-score of 0.81 in an internal dataset and the BERT model fine-tuned with rule-annotated data achieved a macro-F1-score of 0.97 and 0.75 for named entity recognition and relation extraction tasks, respectively. The model can be deployed to other, similar problems in medication-related clinical texts. [ABSTRACT FROM AUTHOR]

Patient identifiers such as name, date of birth, or gender are the first line of defense to ensure the accuracy of the health data displayed in health information exchange. Health data display is the impetus for clinical decisions and patient outcomes and directly correlates with promoting interoperability and health information exchange. Therefore, constant monitoring of quality metrics is imperative for clinical leaders to keep a pulse on what is happening within their organizations. However, the electronic health records (EHRs) designer should also take precautions to ensure the visualizations are not misleading, given that EHRs have been shown in some studies to lead to increased patient safety events. [ABSTRACT FROM AUTHOR]

A foundation for digitally enabling healthier living is the safe development and use of technology. The practice of digital health safety has emerged from patient harm attributed to failing technologies. The study aimed to investigate how to adopt and implement digital health safety guidelines at scale. Data was collected through an online survey, semi-structured interviews, focus groups, document review, and data mining of artefacts. The findings of this study capture the emerging practice from Australia in a way that offers insights into the problem of practice, patient safety practice, safety culture, and socio-technical factors. The research findings contribute to better understanding of the complexities of balancing digital innovation with patient safety. The four recommendations from the study and the provision of a logic model will support the audience to implement actions toward a safer digital health ecology. [ABSTRACT FROM AUTHOR]

Data maps to translate information recorded in one code system to another code system are common in digital health. In the past these were used for data aggregation and national reporting where minor errors caused little impact. Today these maps are used invisibly behind the scenes when sharing clinical data. This is a data quality and safety bomb ready to blow. The International Standards Organization (ISO) have prepared to review their standard on map quality, a standard which when used can identify safety and quality issues in mapped data and assist in development of a pathway to improvement. The key determinants of map quality are discussed here and their impact on patient safety considered based upon real world experiences. Suggestions are included on the potential minimal requirements for any map used in a clinical environment, whether for use for interoperability or for other purposes. Alternatives to encourage improvement in map quality are also suggested. [ABSTRACT FROM AUTHOR]

In the quest to improve the quality of health services and ensure more excellent patient safety, healthcare institutions look for alternatives that could help them achieve this goal. The Lean methodology has been a solution found by these organizations. This study has explored through Lean healthcare literature i) main barriers and facilitators to implementing the Lean approach into healthcare service organizations, and ii) practices and tools of Lean used to improve them continuously. One hundred two documents retrieved from Scopus and Web of Science databases were analyzed to reach the search goals. Through content analysis, the main barriers to Lean program implementation within healthcare institutions are related to resistance to change, low level of staff involvement, firm commitment to a cultural change, departments working in a silo approach, and misunderstanding of Lean concepts and its benefits. On the other hand, the main facilitators are support and engagement by leadership, training, and development of workers, and crossfunctional collaboration. This study also contributes to labeling the most frequent Lean practices and tools -- value stream mapping, fishbone diagram, and SIPOC. The findings of this research provide practical implications since the barriers and facilitators raised from the literature will support healthcare professionals in their Lean healthcare journey in their organizations and consequently improve their competitiveness through a high level of efficiency, quality of care, and practitioner satisfaction. [ABSTRACT FROM AUTHOR]

Healthcare providers are facing increasing pressure to improve service, reduce costs, improve patient safety, reduce waiting times, and reduce errors and associated litigation. The United States spends 22% more than second-ranked Luxembourg, 49%more than third-ranked Switzerland on healthcare per capita, and 2.4 times the average of other OECD countries. In Ontario, healthcare will account for 50% of governmental spending by 2011, two-thirds by 2017, and 100% by 2026 unless a radical approach to healthcare is adopted. In China, 39% of rural and 36% of urban population cannot afford professional medical treatment despite the success of the country's economic and social reforms over the past 25 years (OECD Health Data, 2006). Clothier (2006) estimated that 50% of a clinician's time is not necessary and non-value added in the eyes of the patient. And as per Nino,V. et al., (2021) patient satisfaction can be availed by reducing the delays in registration process. By simplifying processes, lean thinking and lean principles can assist in removing wasteful motion, waiting, and other non-value-added tasks (Wickramasinghe, 2014). [ABSTRACT FROM AUTHOR]

Diabetes type 1 patients require insulin, a life-saving and essential medication, to maintain their blood sugar levels below dangerous levels, which allows them to live everyday life. There are significant issues with insulin supply and affordability in the industry, and as a result, patients and their families face an enormous burden. The high prices of insulin and the lack of availability have led many people to turn to other options for purchasing insulin, such as online pharmacies, which may or may not be legitimate due to their high prices and lack of availability. While diabetics need safe insulin in their legitimate Pharmaceutical Supply Chain (PSC), few researchers have considered implementing strategies to maximize patient safety when buying insulin in the legitimate Pharmaceutical Supply Chain (PSC). This is why the current research is intended to bridge this gap and provide cohesive information on improving insulin safety through the process of overcoming this challenge. This study employs a Multi-Criteria Decision-Making (MCDM) model that combines Supply Chain Operations Reference (SCOR) metrics, Analytic Hierarchy Process (AHP), and Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) to develop a model that can prioritize and select the best criteria for maximizing insulin safety and achieving the study objective. There has been a comparison of two scenarios involving the insulin supply chain that has been carried out. As a result of this research, the integration of a traceability technology to the insulin supply chain, specifically blockchain (T42), in scenario 2 resulted in the best results for the supply chain for maximizing and ensuring the safety of insulin, as compared to scenario 1, where the final score was almost 71%. The research provided a valuable tool for assessing the safety of other critical goods that customers value in strategic and complex decision-making processes, enabling customers to make more informed decisions. Researchers, professionals, and decision-makers can benefit from the results of this research when they can use a rigorous scientific decision-support system to make informed decisions. [ABSTRACT FROM AUTHOR]